The purpose of this study was to compare the pharmacokinetic (the way a drug enters and
leaves the blood and tissues over time) profile of Dilaudid OROS 16mg (Dilaudid Slow Release;
hydromorphone HCL) administered under fasting conditions, following a high-fat breakfast
meal. The study also examined the effect of naltrexone blockade on the pharmacokinetic
profile of Dilaudid SR.

Clinical Details

Official title: An Open-Label Evaluation of the Independent Effect of Coadministration of a High Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCL) 16 mg

Primary outcome: The primary endpoints for the statistical evaluations of the study drug were: Area Under the Concentration-Time Curve from 0 to Infinity and Peak Plasma Concentration.

Secondary outcome: Secondary endpoints were the parameters for the study drug: Area Under the Concentration-Time Curve from 0 to Time t, Time to Peak Plasma Concentration and Terminal Half Life).

Detailed description:
This was a randomized (patients are assigned different treatments based on chance),
open-label, three-way crossover study, performed in normal, healthy adults. Each patient
received orally administered treatments (a different treatment during each dosing phase):
Treatment A: single dose of Dilaudid SR 16 mg administered under fasting conditions without
the naltrexone block;Treatment B: single dose of Dilaudid SR 16 mg administered under fed
conditions without the naltrexone block, Treatment C: single dose of Dilaudid SR 16 mg
administered under fasting conditions with naltrexone HCL 50mg block (3 oral doses of 50mg
each administered 12 hours prior to , at the time of, and 12 hours after Dilaudid SR 16mg
administration). There was a 7-day washout period between dosing phases. Venous blood
sampling times were 0 (prior to dosing),2,4,6,8,10,12,16,20,24,30,36,42,and 48 hours after
each Dilaudid SR administration. LC/MS/MS (Liquid Chromatography/Mass Spectroscopy/Mass
Spectroscopy)techniques were employed for the analysis of plasma for hydromorphone
concentration.

Each patient randomly received orally-administered treatments of single dose of Dilaudid SR
16mg; under fasting conditions without the naltrexone block; under fed conditions without
naltrexone block; under fasting conditions with naltrexone 50mg block (3 oral doses of 50mg
naltrexone HCL each administered 12 hours prior to, at the time of, and 12 hours after
hydromorphone administration); 7-day washout period between dosing phases.

Eligibility

Minimum age: 19 Years.
Maximum age: 50 Years.
Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients were non-smoking, healthy volunteers with body weights between 135 and 220

pounds and within + - 10% of their recommended weight range for their height and body